The Committee for the Implementation of Textile Agreements has announced the fiscal year 2012 (Oct. 1, 2011, through Sept. 30, 2012) limits on apparel imports eligible for duty- and quota-free treatment under the African Growth and Opportunity Act. For apparel articles wholly assembled in one or more beneficiary sub-Saharan African countries from fabric wholly formed in one or more beneficiary countries from yarn originating in the U.S. or one or more beneficiary countries, the FY 2012 limit is 1,877,430,342 square meters equivalent. Of this amount, 938,715,171 SME is available for apparel articles imported under the AGOA third-country fabric provision, which provides preferential treatment for apparel articles assembled in one or more lesser-developed beneficiary countries regardless of the country of origin of the fabric used. Apparel articles entered in excess of these quantities will be subject to otherwise applicable tariffs

BETHESDA, MD - Today, the U.S. Consumer Product Safety Commission (CPSC), Health Canada, and the Consumer Protection Federal Agency of the United Mexican States (Profeco) concluded a first-of-its-kind consumer product safety Summit that was aimed at strengthening the protections for children and consumers throughout North America. The three federal agencies with jurisdiction over consumer products in the United States, Canada, and Mexico issued a joint statement(Español) (pdf) promoting greater cooperation and engagement in ensuring the safety of products made and sold across North America.

According to the U.S. Trade Representative, the North America Free Trade Agreement (NAFTA) among the U.S., Canada, and Mexico created the world’s largest free trade area, linking 450 million people producing $17 trillion worth of goods and services. The increasing volume of global trade and the complexity of global supply chains require cooperation among consumer product safety authorities. The organizations agreed to explore further opportunities for collaboration in the following six areas:

consultation on proposed regulations and voluntary standards,

cooperation on risk assessment,

cooperation on import and market surveillance,

cooperation on training and outreach within and outside North America,

coordinated consumer awareness campaigns, and

consultation on potential joint recalls or corrective actions.

“We are facing common challenges and opportunities to promote product safety, and we can be more effective in protecting consumers in the United States and across North America through collaboration and being proactive,” said CPSC’s Chairman Inez Tenenbaum.

“Having real intelligence to identify product safety risks is vital to reassure the consumers of our countries that we have secure borders, and companies that are committed to the consumer,” said Profeco’s Federal Consumer Attorney, Bernardo Altamirano Rodríguez.

Imports from Mexico and Canada accounted for the second and third largest shares, respectively, of imported consumer products likely to be under CPSC jurisdiction. Both countries share major land borders with the U.S. and products produced in or imported from outside North America to any of our three countries may easily find their way into another partner’s jurisdiction.

“If products can be regulated in a harmonized manner and emerging hazards can be addressed swiftly, then consumers in all three countries can benefit”, said Chairman Tenenbaum.

The joint statement(Español) (pdf) was issued during the First North America Consumer Product Summit hosted by the CPSC. The Summit provided an opportunity for product safety leaders of these countries to lay out their shared visions for enhanced consumer product safety cooperation. Chairman Tenenbaum also noted that the Summit serves as a practical demonstration of support for the principles behind President Obama’s Regulatory Cooperation Council initiatives between the United States and Canada and the United States and Mexico.

During the Summit, CPSC also renewed its Memorandum of Understanding (MOU) (pdf) with Profeco. The MOU describes a framework of cooperation with the goal of reducing the unreasonable risks of injuries and deaths associated with consumer products CPSC already has a MOU with Health Canada in effect.

FDA Participates in Global Efforts to Protect Consumers and Patients from Unsafe Drugs on the Internet

The U.S. Food and Drug Administration and other regulatory and international partners have completed the International Internet Week of Action (IIWA), a cooperative effort to curb online sales and distribution of counterfeit and illegal medical products.

This year’s IIWA, which ran between Sept. 20 and Sept. 27 is called OPERATION PANGEA IV, focused on websites supplying illegal and dangerous medicines. The operation is the largest Internet-based action of its kind in support of the International Medical Products Anti-Counterfeiting Taskforce.

The goal of the IIWA is to protect the public health by increasing the public’s awareness about the dangers and risks associated with purchasing medicines and medical devices from websites, to identify the producers and distributors of counterfeit or otherwise illegal pharmaceutical products or medical devices, to target these individuals or businesses with civil or criminal action, and to seize counterfeit and illegal products and remove them from the supply chain.

“The FDA will continue to work closely with our domestic and international law enforcement and regulatory partners to protect consumers from unapproved and potentially harmful products sold over the internet,” said Dara Corrigan, associate commissioner for regulatory affairs. “We will continue to aggressively pursue those who sell products which may pose a significant risk to consumer health.”

The IIWA also provided an excellent opportunity for the FDA to enhance cooperation with international and domestic regulatory and law enforcement partners to effectively target those involved in the manufacture and distribution of illegal medicines.

FDA’s Office of Criminal Investigations, in conjunction with the Center for Drug Evaluation and Research, and the Office of Enforcement targeted 997 websites that are engaged in the illegal sale of unapproved and/or misbranded medicines to U.S. consumers.

During OPERATION PANGEA IV, FDA focused its efforts on websites selling unapproved drugs, such as drugs containing human growth hormone (HGH), sildenafil citrate, or isotretinoin. These unapproved drugs can be detrimental to public health. Although some drugs containing these active ingredients are approved by FDA for use under the supervision of a licensed medical practitioner, the drugs offered for sale on these websites were not FDA approved, and were offered for sale without requiring a valid prescription.

Improper use of HGH can lead to side effects, including an increased risk of cancer, nerve pain, and elevated cholesterol or glucose levels. Sildenafil citrate tablets are used to treat erectile dysfunction and should not be used in some consumers with heart problems. Isotretinoin capsules, previously marketed as Accutane in the United States, are used to treat severe nodular acne. The drug carries significant potential risks, including severe birth defects if pregnancy occurs while using this medicine.

To minimize potential risks, FDA approved isotretinoin capsules are only available through restricted distribution in the United States, and patients purchasing unapproved products containing this active ingredient are placed at a higher risk because, among other issues, they bypass existing safety controls.

The FDA sent Warning Letters to the operators of the identified websites, all of which appear to be associated with the same individuals and corporate entities located outside of the United States.

As a follow up, the agency sent notices to the Internet Corporation for Assigned Names and Numbers, Registries, Internet Service Providers (ISPs), and Domain Name Registrars (DNRs) informing them that these websites were selling products in violation of U.S. law.

In many cases, conducting illegal activities also violates ISP and DNR policies and agreements, giving the hosting companies the opportunity to terminate the websites and suspend the use of the domain names. Of the 717 websites addressed in the Warning Letters, a total of 578 have been suspended or no longer offer pharmaceuticals for sale. The FDA is working with its foreign counterparts to address the remaining websites, which continue to offer unapproved or misbranded prescription medicines to U.S. consumers.

The IIWA is a coordinated effort by INTERPOL, the World Customs Organization, the Permanent Forum of International Pharmaceutical Crime, the Heads of Medicines Agencies Working Group of Enforcement Officers, as well as national health and law enforcement agencies from 81 participating countries.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Philadelphia — Customs and Border Protection officers seized more than $139,000, most concealed in black socks, from a couple who arrived from Greece Tuesday at Philadelphia International Airport for violating federal currency reporting laws.

The couple, both U.S. citizens over 70 years of age, and whose names aren’t being released as they weren’t charged criminally, admitted to CBP officers that they possessed only $4,000 between them. Officers explained the federal currency reporting requirements. The couple admitted verbally and in writing that they understood, and then declared in writing that they possessed $6,000.

During a baggage inspection, CBP officers discovered five large, bulky, black socks stuffed with U.S. dollars and Euros and lining the sides of two suitcases. CBP officers also discovered additional loose currency inside their luggage and carry-on bags. CBP officers seized a total of $139,349.38.

There is no limit to how much currency travelers can import or export; however federal law requires travelers to declare amounts exceeding $10,000 in U.S. dollars or equivalent foreign currency.

"Travelers who deliberately refuse to comply with federal currency reporting requirements run the risk of losing their currency, and may potentially face criminal charges,” said Allan Martocci, CBP Port Director for the Area Port of Philadelphia. “The easiest way to hold on to your currency is to honestly declare it.”

The couple were provided with directions to petition for their currency and released.

The Committee for the Implementation of Textile Agreements is seeking comments by Oct. 11 on a short supply request alleging that certain cotton/nylon/spandex raschel knit open work crepe fabric, classified under HTSUS 6005.32.00 and 6005.34.00, is not available in commercial quantities in a timely manner from a supplier in the DR-CAFTA countries. The petitioner is therefore requesting that this fabric be added to the short supply list in Annex 3.25 of DR-CAFTA.

Reebok to Pay $25 Million in Customer Refunds To Settle FTC Charges of Deceptive Advertising of EasyTone and RunTone Shoes

In its ongoing effort to stem overhyped advertising claims, the Federal Trade Commission announced that Reebok International Ltd. has agreed to resolve charges that the company deceptively advertised “toning shoes,” which it claimed would provide extra tone and strength to leg and buttock muscles. Reebok will pay $25 million as part of the settlementagreement. The funds will be made available for consumer refunds either directly from the FTC or through a court-approved class action lawsuit. Consumers who bought Reebok toning shoes or toning apparel can submit a claim here.

“The FTC wants national advertisers to understand that they must exercise some responsibility and ensure that their claims for fitness gear are supported by sound science,” said David Vladeck, Director of the FTC’s Bureau of Consumer Protection.

Reebok’s EasyTone walking shoes and RunTone running shoes have retailed for $80 to $100 a pair, while EasyTone flip flops have retailed for about $60 a pair. Ads for the shoes claimed that sole technology featuring pockets of moving air creates “micro instability” that tones and strengthens muscles as you walk or run.

According to the FTC complaint, Reebok made unsupported claims in advertisements that walking in its EasyTone shoes and running in its RunTone running shoes strengthen and tone key leg and buttock (gluteus maximus) muscles more than regular shoes. The FTC’s complaint also alleges that Reebok falsely claimed that walking in EasyTone footwear had been proven to lead to 28 percent more strength and tone in the buttock muscles, 11 percent more strength and tone in the hamstring muscles, and 11 percent more strength and tone in the calf muscles than regular walking shoes.

Beginning in early 2009, Reebok made its claims through print, television, and Internet advertisements, the FTC alleged. The claims also appeared on shoe boxes and displays in retail stores. One television ad featured a very fit woman explaining to an audience the benefits of Reebok EasyTone toning shoes. She picks up a shoe from a display and points to a chart showing the muscles that benefit from use of the shoes, while a video camera continues to focus on her buttocks. She says the shoes are proven to strengthen hamstrings and calves by up to 11 percent, and that they tone the buttocks “up to 28 percent more than regular sneakers, just by walking.”

Under the settlement, Reebok is barred from:

making claims that toning shoes and other toning apparel are effective in strengthening muscles, or that using the footwear will result in a specific percentage or amount of muscle toning or strengthening, unless the claims are true and backed by scientific evidence;

making any health or fitness-related efficacy claims for toning shoes and other toning apparel unless the claims are true and backed by scientific evidence; and

misrepresenting any tests, studies, or research results regarding toning shoes and other toning apparel.

The Commission vote authorizing the staff to file the complaint and approving the proposed consent decreewas 5-0. The FTC filed the complaint and proposed consent decree in the U.S. District Court for the Northern District of Ohio on September 28, 2011. The proposed consent decree is subject to court approval.